The aim of the study is comparison of two attachment systems with four dental implants and overdentures in the upper jaw for patients who experience problems with retention and stability of the upper denture.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Het slecht functioneren van een prothese in de bovenkaak
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Peri-implant bone height changes
Secondary outcome
Implant survival, overdenture survival, the clinical condition of the
peri-implant mucosa, masticatory efficiency and patient satisfaction
Background summary
A number of edentulous patients experiences problems with a conventional
complete upper denture. Lack of retention and stability and an increased
gagging reflex is the main complaint of these patients. An overdenture on
endosseous implants gives the opportunity to improve retention and stability of
the prosthesis and reduce the coverage of the palate.
Study objective
The aim of the study is comparison of two attachment systems with four dental
implants and overdentures in the upper jaw for patients who experience problems
with retention and stability of the upper denture.
Study design
A prospective randomized controlled trial
Intervention
The testgroup will get 4 implants with a ballsuprastructure in combination with
an overdenture in the maxilla. The controlgroup will get 4 implants with a
ballsuprastructure in combination with an overdenture in the maxilla
Study burden and risks
According to the literature, both treatmenst are common treatments for patients
with complaints of retention and stability of the upper denture. So there is no
additional risk for the patients participating in the study. The patients will
get to additional appointments for check-up. The first 1 month after placement
of the overdenture and the second 1 year after placement of the overdenture.
During these visits, the clinical and radiological measurements, the chewing
test and questionnaires regarding patient satisfaction can be completed.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
at least two years edentulous in the upper jaw
problems with retention and stability of the conventional complete denture and/or unpleasant feeling due to extended palatal plate of the denture
Patient is endentulous in the lower jaw
Exclusion criteria
no history of preprosthetic surgery in the upper jaw
no medical contraindications for surgery
patient does not smoke (or is willing to give up smoking six weeks before surgery)
no history of radiotherapy in the head and neck region
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL43293.042.13 |
| OMON | NL-OMON29628 |